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Completed

NCT Number: NCT02034058

Post Market Surveillance Study of the Wingspan Stent System

The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.

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Key information

Conditions

Intracranial Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama-Birmingham, Birmingham, Alabama, United States

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About this study

This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All patients for whom treatment with the Wingspan Stent System is considered.

Treatment and study plan

Wingspan stent system

Device

The Wingspan Stent System is used with the Gateway PTA Balloon Catheter. The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon Catheter is an over-the-wire balloon catheter intended for the pre-dilation of the lesion prior to insertion and deployment of the Wingspan Stent System.

Primary outcomes

  1. Rate of Stroke or Death Among Participants

    Time frame: within 72 hours of the procedure

    The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.

Secondary outcomes

  1. Rate of Ischemic Stroke Among Participants

    Time frame: within 72 hours post procedure

    Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic etiology and is detectable on examination at least 24 hours after onset of symptoms.

  2. Rate of Neurological Death Among Participants

    Time frame: within 72 hours post procedure

    A diagnosis of death by neurological criteria

  3. Rate of Stroke Recovery Among Participants

    Time frame: at 90 days post procedure

    Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.

  4. Rate of Stroke in the Territory of the Stented Artery Among Participants

    Time frame: within 72 hours post procedure

    Stroke in the vascular territory of the stented artery

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Registry information

Official study title

WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Acronym: WEAVE

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2014
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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